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Patient Research Cohort: Rapidly Evolving Multiple Sclerosis (PRC-REMS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Medical Research Council
Imperial College Healthcare NHS Trust
University College, London
Queen Mary University of London
GlaxoSmithKline
University of Cambridge
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01044576
First received: January 7, 2010
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  Purpose

The primary goal of the research cohort is to facilitate patient access to clinical trials testing new therapeutic interventions, or access to second- line treatments.

Secondary objectives of the research cohort study are to obtain detailed clinical phenotyping and immunological analysis of blood samples, aiming to identify and validate biomarkers of disease activity and response to treatment and prognostic markers.


Condition
Relapsing-remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Research Cohort: Rapidly Evolving Multiple Sclerosis Opening the Window of Therapeutic Opportunity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Proportion of research cohort subjects referred into a clinical trial or offered treatment with an appropriate second-line therapy. [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Access and utilization of cohort data. [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Development of bio-markers. [ Time Frame: two years ] [ Designated as safety issue: No ]
  • Development of clinical prognostic markers. [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells


Estimated Enrollment: 200
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Multiple Sclerosis
Patients with relapsing-remitting or secondary progressive multiple sclerosis

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Eligible patients with relapsing-remitting or secondary progressive multiple sclerosis.

Criteria
  • Male or Female, aged 18-65
  • Able to give informed consent
  • Diagnosis of MS according to to the revised McDonald's criteria (Polman et al. Ann Neurol 2005)
  • Relapsing-remitting or secondary progressive MS form
  • Disease duration ≤15 years from diagnosis
  • Expanded disability status scale (EDSS) score 2.0 to 6.0 at screening evaluation

  • Highly active and/or treatment-refractory MS activity defined as:

    1. Two or more clinical exacerbations in the previous 12 months, regardless of treatment; OR:
    2. One clinical exacerbation and sustained increase in EDSS of at least 1 point in the previous 12 months after receiving immune-modifying treatment, OR:
    3. Evidence of gadolinium (contrast)-enhancement or increase of T2 lesion load at MRI after receiving immune-modifying treatment. OR
    4. Not tolerating or not wishing to receive any of the available immune-modifying treatments and meeting one of the stated criteria (b or c) for MS activity in treated subjects (1 relapse and increase in EDSS of at least 1 point in the previous 12 months; or evidence of contrast-enhancement or increase of T2 lesion load at MRI).

Exclusion Criteria:

  • Contraindication to MRI including but not limited to intracranial aneurism clips (except Sugita), history of intra-orbital metal fragments that have not been removed by an MD (as confirmed by orbital X-Ray), pacemaker and non-MR compatible heart valves, inner ear implants, history of claustrophobia or subject feels unable to lie still on their back for a period of 1.5 hours in the MRI scanner.
  • If female, positive urine pregnancy test
  • History or presence of renal impairment (e.g. serum creatinine clearance less than 30ml/min)
  • Inability to give informed consent/comply with study procedures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044576

Locations
United Kingdom
Imperial College NHS Trust
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Medical Research Council
Imperial College Healthcare NHS Trust
University College, London
Queen Mary University of London
GlaxoSmithKline
University of Cambridge
Investigators
Principal Investigator: Paolo A Muraro, MD Imperial College London
  More Information

No publications provided

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01044576     History of Changes
Other Study ID Numbers: CRO1387, G0800679
Study First Received: January 7, 2010
Last Updated: March 12, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service

Keywords provided by Imperial College London:
Multiple Sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013